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← TECVAYLI: refractory multiple myeloma after prior therapy

NCT00006244 · STUDY IN CONTEXT

Melphalan, Peripheral Stem Cell Transplantation, and Interleukin-2 Followed by Interferon Alfa in Treating Patients With Advanced Multiple Myeloma

Draft scope assessment: unclear. Attached because the study's own record describes refractory disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

Overall survival in Multiple Myeloma patients treated with melphalan, IL2-incubated peripheral blood stem cells, and sequential IL2 and interferon maintenance.

Source null

→

primary · POSTED

Evaluate initial response to therapy (complete remission, partial remission, stable response, or progression of disease)

Source null

→

primary · POSTED

Time to Disease Progression

Out of 36 patients, 30 have relapsed and they are used to determine this outcome measure.

→

primary · POSTED

Proportion of Patients Alive and in Remission

Source null

→

secondary · POSTED

Grade 3-4 toxicities by the Bearman common toxicity criteria, encountered by younger (\< 56 years old) advanced multiple myeloma patients treated with melphalan, IL2-incubated peripheral blood stem cells, and sequential IL2.

Of the 36 patients, 20 patients were \<56 years old and these 20 patients are used to determine this outcome measure.

→

secondary · POSTED

Grade 3-4 toxicities by the Bearman common toxicity criteria, encountered by older (≥56 years old) advanced multiple myeloma patients treated with melphalan, IL2-incubated peripheral blood stem cells, and sequential IL2.

Of the 36 patients, 16 patients were ≥56 years old and these 16 are used to determine this outcome measure.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-multiple-myeloma-tecvayli-8bfe04ca
nct id
NCT00006244
trial label
Melphalan, Peripheral Stem Cell Transplantation, and Interleukin-2 Followed by Interferon Alfa in Treating Patients With Advanced Multiple Myeloma
applicability
unclear
applicability note
Attached because the study's own record describes refractory disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
provenance class
registry-condition-search
discovery note
Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count
6
harms Count
1
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-multiple-myeloma-tecvayli-8bfe04ca
    nct id
    NCT00006244
    outcome key
    om-0000
    source section id
    NCT00006244-om-0000
    source outcome index
    0
    endpoint
    Overall Survival
    endpoint definition
    Overall survival in Multiple Myeloma patients treated with melphalan, IL2-incubated peripheral blood stem cells, and sequential IL2 and interferon maintenance.
    time origin
    12.9 Median Years
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-multiple-myeloma-tecvayli-8bfe04ca
    nct id
    NCT00006244
    outcome key
    om-0001
    source section id
    NCT00006244-om-0001
    source outcome index
    1
    endpoint
    Initial Response to Therapy
    endpoint definition
    Evaluate initial response to therapy (complete remission, partial remission, stable response, or progression of disease)
    time origin
    Evaluated at Day +84-90 Post-Transplant
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-multiple-myeloma-tecvayli-8bfe04ca
    nct id
    NCT00006244
    outcome key
    om-0002
    source section id
    NCT00006244-om-0002
    source outcome index
    2
    endpoint
    Time to Disease Progression
    endpoint definition
    Time to Disease Progression
    time origin
    12.9 years (median)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Out of 36 patients, 30 have relapsed and they are used to determine this outcome measure.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-multiple-myeloma-tecvayli-8bfe04ca
    nct id
    NCT00006244
    outcome key
    om-0003
    source section id
    NCT00006244-om-0003
    source outcome index
    3
    endpoint
    Proportion of Patients Alive and in Remission
    endpoint definition
    Proportion of Patients Alive and in Remission
    time origin
    12.9 Median Years
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-multiple-myeloma-tecvayli-8bfe04ca
    nct id
    NCT00006244
    outcome key
    om-0004
    source section id
    NCT00006244-om-0004
    source outcome index
    4
    endpoint
    Number of Patients <56 Years Old Experiencing Grade 3-4 Regimen Related Toxicity
    endpoint definition
    Grade 3-4 toxicities by the Bearman common toxicity criteria, encountered by younger (\< 56 years old) advanced multiple myeloma patients treated with melphalan, IL2-incubated peripheral blood stem cells, and sequential IL2.
    time origin
    First 100 days post-transplant
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Of the 36 patients, 20 patients were \<56 years old and these 20 patients are used to determine this outcome measure.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-multiple-myeloma-tecvayli-8bfe04ca
    nct id
    NCT00006244
    outcome key
    om-0005
    source section id
    NCT00006244-om-0005
    source outcome index
    5
    endpoint
    Number of Patients ≥56 Years Old Experiencing Grade 3-4 Regimen Related Toxicity
    endpoint definition
    Grade 3-4 toxicities by the Bearman common toxicity criteria, encountered by older (≥56 years old) advanced multiple myeloma patients treated with melphalan, IL2-incubated peripheral blood stem cells, and sequential IL2.
    time origin
    First 100 days post-transplant
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Of the 36 patients, 16 patients were ≥56 years old and these 16 are used to determine this outcome measure.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-multiple-myeloma-tecvayli-8bfe04ca
    nct id
    NCT00006244
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Immunotherapy Treatment
    regimen
    Patients receive melphalan IV over 2-3 hours on day -2 and an infusion of IL-2-treated autologous or syngeneic peripheral blood stem cells on day 0. Beginning on day 0, patients also receive IL-2 IV continuously over 5 days followed by 2 days off. Treatment with IL-2 repeats weekly for 4 weeks. Beginning 1 month later, patients undergo maintenance therapy comprising interferon alfa SC 3 times a week in the absence of disease progression or unacceptable toxicity. melphalan: Given IV recombinant interferon alfa: Given SC aldesleukin: Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion in vitro-treated peripheral blood stem cell transplantation: Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion
    analyzed count
    36
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00006244-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-multiple-myeloma-tecvayli-8bfe04ca
    nct id
    NCT00006244
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Immunotherapy Treatment
    regimen
    Patients receive melphalan IV over 2-3 hours on day -2 and an infusion of IL-2-treated autologous or syngeneic peripheral blood stem cells on day 0. Beginning on day 0, patients also receive IL-2 IV continuously over 5 days followed by 2 days off. Treatment with IL-2 repeats weekly for 4 weeks. Beginning 1 month later, patients undergo maintenance therapy comprising interferon alfa SC 3 times a week in the absence of disease progression or unacceptable toxicity. melphalan: Given IV recombinant interferon alfa: Given SC aldesleukin: Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion in vitro-treated peripheral blood stem cell transplantation: Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion
    analyzed count
    36
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00006244-om-0001#groups/OG000
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-multiple-myeloma-tecvayli-8bfe04ca
    nct id
    NCT00006244
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Immunotherapy Treatment
    regimen
    Patients receive melphalan IV over 2-3 hours on day -2 and an infusion of IL-2-treated autologous or syngeneic peripheral blood stem cells on day 0. Beginning on day 0, patients also receive IL-2 IV continuously over 5 days followed by 2 days off. Treatment with IL-2 repeats weekly for 4 weeks. Beginning 1 month later, patients undergo maintenance therapy comprising interferon alfa SC 3 times a week in the absence of disease progression or unacceptable toxicity. melphalan: Given IV recombinant interferon alfa: Given SC aldesleukin: Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion in vitro-treated peripheral blood stem cell transplantation: Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion
    analyzed count
    30
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00006244-om-0002#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-multiple-myeloma-tecvayli-8bfe04ca
    nct id
    NCT00006244
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Immunotherapy Treatment
    regimen
    Patients receive melphalan IV over 2-3 hours on day -2 and an infusion of IL-2-treated autologous or syngeneic peripheral blood stem cells on day 0. Beginning on day 0, patients also receive IL-2 IV continuously over 5 days followed by 2 days off. Treatment with IL-2 repeats weekly for 4 weeks. Beginning 1 month later, patients undergo maintenance therapy comprising interferon alfa SC 3 times a week in the absence of disease progression or unacceptable toxicity. melphalan: Given IV recombinant interferon alfa: Given SC aldesleukin: Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion in vitro-treated peripheral blood stem cell transplantation: Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion
    analyzed count
    36
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00006244-om-0003#groups/OG000
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-multiple-myeloma-tecvayli-8bfe04ca
    nct id
    NCT00006244
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Immunotherapy Treatment
    regimen
    Patients receive melphalan IV over 2-3 hours on day -2 and an infusion of IL-2-treated autologous or syngeneic peripheral blood stem cells on day 0. Beginning on day 0, patients also receive IL-2 IV continuously over 5 days followed by 2 days off. Treatment with IL-2 repeats weekly for 4 weeks. Beginning 1 month later, patients undergo maintenance therapy comprising interferon alfa SC 3 times a week in the absence of disease progression or unacceptable toxicity. melphalan: Given IV recombinant interferon alfa: Given SC aldesleukin: Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion in vitro-treated peripheral blood stem cell transplantation: Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion
    analyzed count
    20
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00006244-om-0004#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-multiple-myeloma-tecvayli-8bfe04ca
    nct id
    NCT00006244
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Immunotherapy Treatment
    regimen
    Patients receive melphalan IV over 2-3 hours on day -2 and an infusion of IL-2-treated autologous or syngeneic peripheral blood stem cells on day 0. Beginning on day 0, patients also receive IL-2 IV continuously over 5 days followed by 2 days off. Treatment with IL-2 repeats weekly for 4 weeks. Beginning 1 month later, patients undergo maintenance therapy comprising interferon alfa SC 3 times a week in the absence of disease progression or unacceptable toxicity. melphalan: Given IV recombinant interferon alfa: Given SC aldesleukin: Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion in vitro-treated peripheral blood stem cell transplantation: Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion
    analyzed count
    16
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00006244-om-0005#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-multiple-myeloma-tecvayli-8bfe04ca
    nct id
    NCT00006244
    harm key
    EG000
    source section id
    NCT00006244-ae
    event group key
    EG000
    event group label
    Immunotherapy Treatment
    serious affected
    10
    serious at risk
    36
    other affected
    0
    other at risk
    36
    frequency threshold
    5
    collection period
    Source null
    event definition
    Source null
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
quality of life
    setting source links

      Preserved source evidence · Not medical advice